Problem Formulation for Human Health Risk Assessments of Pathogens in Land-Applied Biosolids (External Review Draft)

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This is a draft document and as such has not been formally disseminated by the U.S. EPA; it does not represent - and should not be construed to represent - any U.S. EPA policy or determination. Under applicable information quality guidelines, the document is being released for a 45-day public comment period.

In 2002 the National Research Council released a report entitled, Biosolids Applied to Land: Advancing Standards and Practice. To address the issues raised by that report, in January 2004, EPA released an Action Plan for setting new priorities for the biosolids program. This draft document is an important step in that action plan because it provides concepts and planning methods for consideration and possible use in the conduct of risk assessments focusing on pathogens in land-applied biosolids. The document summarizes the existing literature; defines critical pathogen stressors; develops conceptual models linking the most likely stressors, pathways and health responses of concern; evaluates the overall quality and utility of available risk assessment data, tools and methodologies; and outlines an analysis plan that identifies research and methods for conducting a scientifically defensible risk assessment relevant to EPA’s decision needs.


EPA intends to release all public comments received by the due date posted in the Federal Register Notice, for use by the external review panel during the peer-review workshop.

EPA intends to review comments from both the general public and the external peer-review workshop when publishing the final document.


U.S. EPA. Problem Formulation for Human Health Risk Assessments of Pathogens in Land-Applied Biosolids (External Review Draft). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-08/035A, 2010.


Jan 2004EPA releases final Action Plan for setting priorities.
Oct 2007Document submitted for internal peer review.
Sep 2008EPA releases the External Peer Review document for public review and comment.

Additional Information

Public Comment Period Instructions for comment submissions can be found by reviewing the document federal register notice announcement. Questions about comment submissions and the public-comment period can be directed to the:
    OEI Docket Center
    Telephone - 202-566 -1752
    Fax - 202-566 -1753
    E-mail -
External Peer-Review Workshop Information (November 19, 2008) The external peer-review workshop will be held at the U.S. Environmental Protection Agency’s Andrew W. Breidenbach Environmental Research Center, 26 W. Martin Luther King Drive, Cincinnati, OH 45268. An indenpendent contractor, ERG, is organizing, convening and conducting the external peer-review workshop.

Register for the workshop: When making reservations to attend the external peer-review workshop, individuals must indicate whether they plan to provide brief oral comments to the external review panel. Space is limited, and reservations will be accepted on a first-come, first-served basis.

Note: Workshop registration deadline is November 12, 2008